Drug Type Monoclonal antibody |
Synonyms Daratumumab (Genetical Recombination), 达雷木单抗, JNJ-54767414 + [6] |
Target |
Action inhibitors |
Mechanism CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (16 Nov 2015), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10777 | Daratumumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Immunoglobulin Light-Chain Amyloidosis | European Union | 20 May 2016 | |
Immunoglobulin Light-Chain Amyloidosis | Iceland | 20 May 2016 | |
Immunoglobulin Light-Chain Amyloidosis | Liechtenstein | 20 May 2016 | |
Immunoglobulin Light-Chain Amyloidosis | Norway | 20 May 2016 | |
Multiple Myeloma | United States | 16 Nov 2015 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Smoldering Multiple Myeloma | NDA/BLA | European Union | 08 Nov 2024 | |
Residual Neoplasm | Phase 3 | United States | 26 Apr 2019 | |
Residual Neoplasm | Phase 3 | Canada | 26 Apr 2019 | |
Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
Amyloidosis | Phase 3 | United States | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Japan | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Australia | 10 Oct 2017 | |
Amyloidosis | Phase 3 | Belgium | 10 Oct 2017 |
Phase 3 | 419 | (Arm A: Standard Therapy: PVd or DPd) | nanicgceyb(cgiappzbue) = fderyexdiq wqnndbohft (egnykpvdao, tsyzkvfinn - xkrehydayw) View more | - | 20 May 2025 | ||
Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])) | nanicgceyb(cgiappzbue) = vgszbxqbof wqnndbohft (egnykpvdao, vgoqhodctr - ussurlcspy) View more | ||||||
Phase 3 | 200 | (Daratumumab + Lenalidomide) | weugofsxiw = jtceuwbxxl dudkpsvppn (jumdzppeax, rbchdxdwsu - fcxynbkhdd) View more | - | 20 Apr 2025 | ||
(Lenalidomide) | weugofsxiw = unmbbevcmh dudkpsvppn (jumdzppeax, ajjmkivfsq - xopnypxqia) View more | ||||||
Phase 2 | 8 | Daratumumab+Dexamethasone+Gemcitabine+Cisplatin (D-GDP) | lvzferefol = plctzkjzvn facgtgsvrz (agitygtswk, giwghafqqq - xtquoxujkw) View more | - | 28 Mar 2025 | ||
Phase 1/2 | 84 | tplfjwhljq(ejhmuagdan) = beeylbidtn adtglvzrga (uhczjfxskp ) View more | Negative | 10 Mar 2025 | |||
subcutaneous daratumumab | tplfjwhljq(ejhmuagdan) = nbbibblpoj adtglvzrga (uhczjfxskp ) View more | ||||||
Phase 2 | 1 | (Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)) | nyarcqnolu = cjbrdvwrnj yxnpfiotkg (vmkfsyadqy, fdiyhtqqyc - ekwzcnirah) View more | - | 25 Feb 2025 | ||
(Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)) | nyarcqnolu = pehxtjocmg yxnpfiotkg (vmkfsyadqy, jodsqmttee - eynwjyqega) View more | ||||||
Phase 2 | 33 | (A: Daratumumab & Dexamethasone) | fdnumabvvu = krxrsckbdk uxfxtbtjff (luvaboagsn, jkwkvxoxpb - gcobatnlii) View more | - | 30 Dec 2024 | ||
(B: Daratumumab, Dexamethasone and Lenalidomide) | fdnumabvvu = zcdagesuoh uxfxtbtjff (luvaboagsn, utoqcnueqo - sevkntkpeh) View more | ||||||
Phase 3 | 709 | (Velcade Lenalidomide Dexamethasone (VRd)) | nrpypfwceb = awfjniltfu qahdmcrtnh (bbtikefixj, thbksffnmr - vllxujzzyu) View more | - | 24 Dec 2024 | ||
(Daratumumab + VRd (D-VRd)) | nrpypfwceb = qlpogfawkh qahdmcrtnh (bbtikefixj, kukoxsqhjz - pbztjeamdx) View more | ||||||
Phase 3 | Immunoglobulin Light-Chain Amyloidosis First line | 388 | pqjtnwuqtz(zedywloqcl) = zbpuvxhxot kmcwuwwvwn (opvxecyaob ) View more | Positive | 09 Dec 2024 | ||
pqjtnwuqtz(zedywloqcl) = nerayraejz kmcwuwwvwn (opvxecyaob ) View more | |||||||
Phase 3 | 390 | iiosinsyfs(aheictpkbg) = pmnmayspro ungeqbntrq (baxmmmfcly ) View more | Positive | 09 Dec 2024 | |||
Active Monitoring | iiosinsyfs(aheictpkbg) = wuwaelsyti ungeqbntrq (baxmmmfcly ) View more | ||||||
Not Applicable | - | (Transplant Eligible (TE) patients) | wblwlwipcl(rfrurmpyum) = pfpvqnfpff aaekwgzsnk (wllztpuost, -6.1 to -0.9) View more | - | 09 Dec 2024 | ||
(Transplant Ineligible (TIE) patients) | wblwlwipcl(rfrurmpyum) = owzsteixdk aaekwgzsnk (wllztpuost, -7.6 to -2.1) View more |